Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest (HETOCA)

Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest: Advancing Advanced Life Support Towards Goal Directed Resuscitation

This study seeks to evaluate, whether patients suffering from cardiac arrest, that can be successfully resuscitated, can be differentiated from those, that cannot be resuscitated, using arterial blood pressure values.

Study Overview

• Status: Suspended
• Conditions: Cardiac Arrest

Detailed Description

Cardiopulmonary resuscitation (CPR) in patients suffering from cardiac arrest out of hospitals is based on strict clinical practice guidelines. However, the evidence base for these treatment recommendation is insufficient in many respects. While knowledge about basic interventions, that are capable of restoring spontaneous circulation and improving neurologically intact survival - chest compressions, application of oxygen and early defibrillation -, has increased over the last decade, advanced treatment options - advanced airway management, vascular access, application of vasoactive drugs - are still recommended, although clinical trials of varying quality failed to demonstrate any benefit in patient related outcomes.

This study seeks to establish hemodynamic threshold values that are able to discriminate between patients that achieve return of spontaneous circulation (survivors) and those that fail to do so (non-survivors). These cutoff values could act as targets for interventions during CPR (i.e. application of vasoactive drugs, use of mechanical compression devices, …) in further trials and may potentially influence clinical practice later on. Furthermore, reliable cutoff values could act as additional prognostic factors during CPR, enabling prehospital care providers to base their decisions to continue or terminate ongoing CPR efforts on a more solid basis.

To achieve this goal, 22 patients with out-of-hospital cardiac arrest (OHCA) treated by physicians of the prehospital physician response system located at the Medical University of Graz shall be included into this trial. All patients will receive Advanced Life Support (ALS) interventions according to current guidelines issued by the European Resuscitation Council (ERC). In addition, arterial lines will be placed and arterial blood pressure will be measured continuously. This intervention is already considered standard of care at this prehospital physician response system and performed routinely as part of the local ALS algorithm.

Relevant parameters - systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP) etc. - will be documented electronically using both the electronic documentation system already used by the prehospital physician response system and the monitor/defibrillator device. Median values will be compared between survivors and non-survivors and possible threshold values will be calculated. Cutoff values that would be best suited to act as targets in future research and clinical practice will be identified by receiver operating characteristics (ROC).

• Study Type: Observational
• Enrollment (Estimated): 22

Contacts and Locations

• Study Contact: Name: Paul Zajic, MD; Phone Number: 80609 +43 (0) 316 385; Email: paul.zajic@medunigraz.at
• Study Contact Backup: Name: Gerhard Prause, MD; Phone Number: 81170 +43 (0) 316 385; Email: gerhard.prause@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Prehospital Physician Response System, Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients suffering from cardiac arrest on arrival of the physician response unit are to be included, if ALS is deemed reasonable by the emergency physician. The groups to be compared are survivors (patients with sustained return of spontaneous circulation (ROSC) in the field who are transported to a hospital alive) and non-survivors (patients in whom CPR is terminated in the field).

Description

Inclusion Criteria

• Out-of-hospital cardiac arrest
• Age >18 years
• Advanced Life Support started
• Arterial line placement possible

Exclusion Criteria

• Obvious signs of death
• Advanced Directives / Do Not Attempt Resuscitation Order
• Cardiac arrest of traumatic etiology
• Documented patient refusal in advance

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Survivors; Patients suffering from out-of-hospital cardiac arrest (OHCA), who achieve sustained return of spontaneous circulation (ROSC) following prehospital cardiopulmonary resuscitation.
Non-Survivors; Patients suffering from out-of-hospital cardiac arrest (OHCA), who are declared dead after prehospital cardiopulmonary resuscitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Blood Pressure	Mean arterial blood pressure measured invasively via the arterial line.	immediately after placement of the arterial line

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Arterial Blood Pressure	Systolic arterial blood pressure measured invasively via the arterial line.	immediately after placement of the arterial line
Diastolic Arterial Blood Pressure	Diastolic arterial blood pressure measured invasively via the arterial line.	immediately after placement of the arterial line
Mean Arterial Blood Pressure	Mean arterial blood pressure measured invasively via the arterial line.	one minute after the first application of epinephrine following placement of the arterial line
Systolic Arterial Blood Pressure	Systolic arterial blood pressure measured invasively via the arterial line.	one minute after the first application of epinephrine following placement of the arterial line
Diastolic Arterial Blood Pressure	Diastolic arterial blood pressure measured invasively via the arterial line.	one minute after the first application of epinephrine following placement of the arterial line
Mean Arterial Blood Pressure	Mean arterial blood pressure measured invasively via the arterial line.	five minutes after placement of arterial line
Systolic Arterial Blood Pressure	Systolic arterial blood pressure measured invasively via the arterial line.	five minutes after placement of arterial line
Diastolic Arterial Blood Pressure	Diastolic arterial blood pressure measured invasively via the arterial line.	five minutes after placement of arterial line

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Paul Zajic, MD, Div. of General Anaesthesiology, Emergency- and Intensive Care Medicine, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: HETOCA-2017-v1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Informed Consent Form
2. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No